PATIENT INFORMATION

Read this Patient Information before you are treated with Metvixia (methyl aminolevulinate cream) Cream and
each time you are treated. There may be new information. This leaflet does not
take the place of talking with your doctor about your condition or treatment.
Ask your doctor provider about anything you do not understand about Metvixia (methyl aminolevulinate cream)
Cream.

Important note: Metvixia (methyl aminolevulinate cream) is for use on the skin only. Tell your doctor
right away if Metvixia (methyl aminolevulinate cream) gets in your eyes or mouth.

What is the most important thing I need to know about Metvixia (methyl aminolevulinate cream) Cream?

Metvixia (methyl aminolevulinate cream) Cream is not applied by patients and should not be applied by doctors
who have not been trained in its use.

Metvixia (methyl aminolevulinate cream) cream is for use in PDT with the Aktilite CL128 lamp.

What is Metvixia (methyl aminolevulinate cream) Cream?

Metvixia (methyl aminolevulinate cream) Cream is a prescription cream used with PDT to treat skin growths
on the face and scalp called actinic keratosis (AK). Metvixia (methyl aminolevulinate cream) Cream is only
used for AK skin growths that are thin and not dark colored. AK skin growths
are caused partly by too much sun exposure. Metvixia (methyl aminolevulinate cream) Cream and PDT work together
to treat AK skin growths.

Metvixia (methyl aminolevulinate cream) Cream has not been studied in children for any condition and should
not be used in children.

Who should not use Metvixia (methyl aminolevulinate cream) Cream?

Do not use Metvixia (methyl aminolevulinate cream) Cream if:

your skin over reacts to sun or light (photosensitivity); Talk with your
doctor to be sure

you are allergic to porphyrins or to any of the ingredients in Metvixia (methyl aminolevulinate cream)
Cream including peanut and almond oil. See the end of this leaflet for a complete
list of ingredients in Metvixia (methyl aminolevulinate cream) Cream.

What should I tell my doctor before treatment with Metvixia (methyl aminolevulinate cream) Cream?

are pregnant or planning to become pregnant. It is not known if Metvixia (methyl aminolevulinate cream)
Cream can harm your unborn baby.

are breastfeeding. It is not known if Metvixia (methyl aminolevulinate cream) Cream passes into
your milk and if it can harm your baby. You should decide whether or not to
stop breastfeeding while getting treatment with Metvixia (methyl aminolevulinate cream) Cream. Talk to your
doctor for help with this choice.

Tell your doctor about all the medicines you take, including prescription
and nonprescription medicines, vitamins and herbal supplements. It is not
known if Metvixia (methyl aminolevulinate cream) Cream and other medicines can affect each other.

Know your medicines. Keep a list of your medicines and show it to your doctor
and pharmacist when you start a new medicine.

You will receive 2 treatments with Metvixia (methyl aminolevulinate cream) Cream and PDT 1 week apart.
Your doctor will check you three months after treatment to see if the treatment
worked for you. (See the end of this leaflet for the section “Treatment
with Metvixia (methyl aminolevulinate cream) Cream and PDT.”)

Metvixia (methyl aminolevulinate cream) Cream is for skin use only. Do not get Metvixia (methyl aminolevulinate cream) Cream in your eyes
or mouth. Tell your doctor right away if this happens.

What should I avoid while using Metvixia (methyl aminolevulinate cream) Cream?

During the 3 hours that Metvixia (methyl aminolevulinate cream) Cream is on your skin:

Avoid sunlight or bright indoor light (for example: examination lights,
operating room lights, tanning beds or lights that are close to you).
During this time, the treated areas of your skin are more sensitive to
light. You may feel burning or stinging. Your treated skin may become
red or your lesions may become swollen. Wear a protective hat and clothing
if you need to be outside in the sun.

After treatment with Metvixia (methyl aminolevulinate cream) cream and PDT, avoid sunlight or bright
indoor light (for example: examination lights, operating room lights, tanning
beds or lights that are close to you) for two days. During this time, the
treated areas of your skin are more sensitive to light. Keep the treated areas
of your skin covered. Wear a protective hat and clothing if you need to be
outside in the sun.

If for any reason you are not treated with the lamp after Metvixia (methyl aminolevulinate cream) Cream
has been applied to your skin:

Carefully rinse off the Cream.

Avoid sunlight, indoor light that is bright (for example: examination
lights, operating room lights, tanning beds or lights that are close to
you) for two days after treatment. During this time, the treated areas
of your skin are more sensitive to light. Wear a protective hat and clothing
if you need to be outside in the sun.

What are the possible side effects of Metvixia (methyl aminolevulinate cream) Cream with PDT treatment?

Common side effects of Metvixia (methyl aminolevulinate cream) Cream with PDT treatment include the following
skin reactions at the treated site:

This leaflet summarizes the most important information about Metvixia (methyl aminolevulinate cream) Cream.
If you would like more information, talk with your doctor. You can ask your
doctor for information about Metvixia (methyl aminolevulinate cream) Cream that is written for health professionals.

Toll-free number and/or website will be provided when available for the
US market.

Your doctor will prepare your skin by gently scraping (debriding) your skin
growths before treating with Metvixia (methyl aminolevulinate cream) Cream and PDT. A small skin scraper is
used to remove scales and crusts and to roughen the surface of any skin growths.
This is to help Metvixia (methyl aminolevulinate cream)

Cream and PDT to reach all parts of the skin growths.

Figure 2: Cream application

Metvixia (methyl aminolevulinate cream) Cream is applied to the actinic keratosis skin growths and to a small
area of the skin around the growths.

Figure 3: Clear bandage application

The treated skin areas will be covered with a special clear bandage for about
3 hours.

During these 3-hours avoid sunlight or bright indoor light (for example: examination
lights, operating room lights, tanning beds or lights that are close to you).
During this time, the treated areas of your skin are more sensitive to light.
You may feel burning or stinging. Your treated skin area may turn red or become
swollen (photosensitive reactions). Wear a hat and protective clothes if you
need to be out in the sun during this time. Sunscreens will not help protect
your treated skin during this time. In cold weather, protect your treated skin
site from the cold with warm clothes or stay indoors for these 3 hours between
the cream and light treatment.

Figure 4: Cream removal

The bandage will be removed and the area will be rinsed with a saline solution
before the PDT (light) treatment.

Figure 5: Positioning the lamp

The lamp will be positioned over the area to be illuminated by the use of guide
light of reduced intensity. The distance between the lamp and the skin will
be 50 to 80 mm (2- 3.2 inch).

Figure 6: Illumination

The skin growth will be treated with PDT. PDT lasts about 10 minutes for each
area treated with the lamp. You and your doctor will wear goggles to cover and
protectyour eyes from the light during this part of the treatment. Do not stare
into the beam.

More than 1 skin growth may be treated at a time. Your treated skin areas may
burn, feel painful, sting, or tingle during light treatment. The Aktilite light
treatment can be stopped for a short period of time (paused) and then restarted
if needed. Tell your doctor to stop the light if you need the treatment paused
because of discomfort, or if you need to adjust your goggles. If you cannot
have the light treatment 3 hours after Metvixia (methyl aminolevulinate cream) Cream is applied, rinse the
cream off your skin, protect your skin from sunlight and bright indoor light
(for example: examination lights, operating room lights, tanning beds or lights
that are close to you) for two days.

Last reviewed on RxList: 8/4/2008
This monograph has been modified to include the generic and brand name in many instances.